General Discussions

Four companies drew the ire of the FDA this week for claiming that their products, derived from marijuana, can treat or even cure cancer.

The agency issued warning letters to the companies, stating that they made unsubstantiated claims about more than 25 products on webpages and social media sites, and in online stores. The companies — Greenroads Health, Natural Alchemist, That’s Natural! Marketing and Consulting, and Stanley Brothers Social Enterprises, LLC — claimed that their products could prevent, diagnose, treat or cure cancer, but the FDA said the sellers did not have evidence to support those claims.

The agency then issued a press release about the letters to put other companies on notice.

“Selling these unapproved products with unsubstantiated therapeutic claims is not only a violation of the Federal Food, Drug and Cosmetic Act, but also can put patients at risk, as these products have not been proven to be safe or effective,” the press release stated. And worse, “the deceptive marketing of unproven treatments may keep some patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases.”

All of the companies that received letters were selling products — such as oil drops, teas or lotions — that were purported to contain cannabidiol (CBD), a component of the marijuana plant that has not been approved by the FDA as a treatment for any illness. Regarding the products cited in the letters, the agency said it has not considered their effectiveness, proper dosage or potential for dangerous side effects or drug interactions.

“Substances that contain components of marijuana will be treated like any other products that make unproven claims to shrink cancer tumors. We don’t let companies market products that deliberately prey on sick people with baseless claims that their substance can shrink or cure cancer, and we’re not going to look the other way on enforcing these principles when it comes to marijuana-containing products,” said FDA Commissioner Scott Gottlieb, M.D. “We recognize that there’s interest in developing therapies from marijuana and its components, but the safest way for this to occur is through the drug approval process — not through unsubstantiated claims made on a website. We support sound, scientifically based research using components derived from marijuana, and we’ll continue to work with product developers who are interested in bringing safe, effective and quality products to market.”

The FDA has requested that the companies respond with explanations of how they will correct the violations. If they fail to make these corrections, the companies may face legal action, including the seizure of their products and court orders to stop falsely marketing or selling the items.

This latest action is part of a larger effort by the FDA to stop companies from fraudulently claiming — on websites, social media and in stores — that their products can improve the health of patients with cancer. The effort has included the issuing of 90 warning letters in the past 10 years, including more than a dozen this year, to companies using such claims to market hundreds of products. The FDA also recently seized vials of a live virus vaccine from “stem cell” centers that were marketing a potentially dangerous and unproven treatment to patients with cancer.

The FDA is asking health care professionals and consumers to report adverse reactions associated with these or similar products to its MedWatch program.